Medical devices and related methods

ABSTRACT

A medical device includes a handle with a proximal arm and a distal arm. The proximal arm and the distal arm are pivotable via a joint. The medical device also includes a tube coupled to the distal arm and a drive wire. A distal portion of the drive wire includes an expandable end effector. A portion of the drive wire is positioned within the tube, and a different portion of the drive wire extends proximally of the distal arm and is coupled to the proximal arm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is continuation of U.S. application Ser. No.16/298,223, filed Mar. 11, 2019, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Patent Application No.62/641,808 and U.S. Provisional Patent Application No. 62/641,822, bothfiled on Mar. 12, 2018, all of which are herein incorporated byreference in their entireties.

TECHNICAL FIELD

Various aspects of the present disclosure relate generally to medicaldevices and related methods. More specifically, the present disclosurerelates to medical devices and methods for providing and regulatingirrigation and/or suction in a medical retrieval procedure.

BACKGROUND

Medical procedures to remove material, such as a kidney stone, from apatient often use an expandable basket device. For example, during apercutaneous nephrolithotomy (“PCNL”) procedure, a user may applyenergy, for example, with a pneumatic or ultrasonic probe through anephroscope or other insertion device, to a kidney stone to break-up orreduce the size of the kidney stone. Then, the user may remove smallerfragments with suction applied through a suction tube, and the user mayremove larger fragments with a basket device. The user may repeatedlyapply the suction and actuate the basket device based on the size and/ornumber of kidney stone particles and other material to be removed. Theprocedure may require additional energy application and/or irrigation aswell. However, using different medical devices requires the user tocontinuously exchange the long medical devices through the insertiondevice. Exchanging and positioning the different medical devices mayincrease the duration and risks of the procedure.

Additionally, if the stone or material is captured in a basket devicebut is too large to be removed, it may be necessary to apply energy tothe stone within the basket device. The basket sheath may occupy much ofthe cross-sectional area within the insertion device, preventinginsertion of the energy device to target the stone. Therefore, the usermay seek to remove the basket sheath from the insertion device withoutremoving the basket drive wire. However, the user may be holding theinsertion device and the basket device, so removing the basket sheathwould require an additional medical professional, further increasing theduration and risks of the procedure.

The devices and methods of the current disclosure may rectify some ofthe deficiencies described above, and/or address other aspects of theprior art.

SUMMARY

Examples of the present disclosure relate to, among other things,medical devices and methods. Each of the examples disclosed herein mayinclude one or more of the features described in connection with any ofthe other disclosed examples.

In one example, a medical device may include a handle with a proximalarm and a distal arm. The proximal arm and the distal arm may bepivotable via a joint. The medical device also may include a tubecoupled to the distal arm and a drive wire. A distal portion of thedrive wire may include an expandable end effector. A portion of thedrive wire may be positioned within the tube, and a different portion ofthe drive wire may extend proximally of the distal arm and may becoupled to the proximal arm.

The medical device may further include one or more of the followingfeatures. A proximal end of the drive wire may be releasably coupled tothe proximal arm via a drive wire clip. The drive wire clip may bedepressible and slotted, and the drive wire clip may be movable in adirection transverse to the drive wire to uncouple the drive wire fromthe proximal arm. The drive wire clip may be biased toward an extendedposition by a spring within the proximal arm. The medical device may beconfigured to be held in a user's hand, and the drive wire clip may beconfigured to be actuated by a thumb of the user's hand.

The medical device may further include a lever, and the tube may befixedly coupled to the lever. The lever may be slidably positionedwithin a slot in an extension extending distally from the distal arm.When the proximal arm and the distal arm are compressed together, theexpandable end effector may extend from a distal end of the tube to forma first size or shape, and proximal movement of the lever when theproximal arm and the distal arm are compressed may further expand theexpandable end effector to form a second size or shape. The medicaldevice may be configured to be held in a user's hand, and the lever maybe configured to be actuated by a finger of the user's hand.

The medical device may further include a distal extension extendingdistally from the distal arm. The distal extension may include aproximal portion and a distal portion, and the proximal portion and thedistal portion may be connected by at least one bridge element. Themedical device may further include a rotary knob positioned between theproximal portion and the distal portion of the distal extension, and therotary knob may radially surround a portion of the drive wire. Themedical device may further include a shaft element positioned radiallybetween the drive wire and the rotary knob, and the shaft element may befixedly coupled to the drive wire. The shaft element and the rotary knobmay each include at least one engaging surface such that rotation of therotary knob in a first direction causes the shaft element to also rotatein the first direction. The shaft element may slide freely in alongitudinal direction through the rotary knob, and rotation of therotary knob in the first direction may cause the drive wire and theexpandable end effector to also rotate in the first direction.

In another example, a medical device may include a handle including aproximal arm, a distal arm, a distal extension extending from the distalarm, and a lever slidably positioned within a slot in a portion of thedistal extension. The medical device may also include a tube positionedwithin a portion of the distal extension and fixedly coupled to thelever, and proximal movement of the lever may move the tube proximally.The medical device may further include a drive wire, and a distalportion of the drive wire may include an expandable retrieval device. Aportion of the drive wire may be positioned within the tube, and adifferent portion of the drive wire may extend proximally of the distalarm and may be coupled to the proximal arm.

The medical device may further include one or more of the followingfeatures. A proximal end of the drive wire may be releasably coupled tothe proximal arm via a drive wire clip. The drive wire clip may bedepressible and slotted, and the drive wire clip may be movable in adirection transverse to the drive wire to uncouple the drive wire fromthe proximal arm. The drive wire clip may be biased toward an extendedposition by a spring within the proximal arm. The medical device may beconfigured to be held in a user's hand, and the drive wire clip may beconfigured to be actuated by a thumb of the user's hand.

In a further example, a medical device may include a handle including aproximal arm, a distal arm, a distal extension extending from the distalarm, and a rotary knob partially surrounded by one or more portions ofthe distal extension. The medical device may also include a tube coupledto the distal extension distal to the rotary knob, and a drive wirecoupled to an end effector. A portion of the drive wire may bepositioned within the tube, and a different portion of the drive wiremay extend proximally of the distal arm and may be coupled to theproximal arm. The medical device may further include a shaft elementradially surrounding and fixedly coupled to a portion of the drive wire,and the shaft element may be positioned radially between a portion ofthe drive wire and the rotary knob.

The medical device may further include one or more of the followingfeatures. The shaft element and the rotary knob may each include atleast one engaging surface such that rotation of the rotary knob in afirst direction causes the shaft element to also rotate in the firstdirection. The end effector may include an expandable retrieval basket,and the shaft element may slide freely in a longitudinal directionthrough the rotary knob. Rotation of the rotary knob in the firstdirection may cause the drive wire and the expandable retrieval basketto rotate in the first direction.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the features, as claimed. As used herein, the terms “comprises,”“comprising,” “including,” “having,” or other variations thereof, areintended to cover a non-exclusive inclusion such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements, but may include other elements not expressly listedor inherent to such a process, method, article, or apparatus.Additionally, the term “exemplary” is used herein in the sense of“example,” rather than “ideal.” As used herein, the terms “about,”“substantially,” and “approximately,” indicate a range of values within+/−5% of the stated value.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various exemplary embodiments andtogether with the description, serve to explain the principles of thedisclosure.

FIG. 1 illustrates a medical device, according to aspects of the presentdisclosure.

FIG. 2A illustrates a schematic view of an axial cross-section of themedical device of FIG. 1 , and FIG. 2B illustrates an cross-sectionalview of a portion of the medical device of FIG. 1 , according to aspectsof the present disclosure.

FIG. 3 illustrates a schematic view of an axial cross-section of afurther exemplary medical device, according to aspects of the presentdisclosure.

FIG. 4 illustrates a perspective and partially exploded view of aportion of an additional medical device, according to additional aspectsof the present disclosure.

FIGS. 5A and 5B illustrate perspective views of a portion of a furthermedical device, according to further aspects of the present disclosure.

FIG. 6A illustrates a side view of a portion of an additional medicaldevice, and FIG. 6B illustrates a perspective view of a portion of theadditional medical device, according to additional aspects of thepresent disclosure.

FIG. 7A illustrates a side view of a portion of yet another medicaldevice, and FIG. 7B illustrates a cross-sectional view of a portion ofthe medical device, according to further aspects of the presentdisclosure.

DETAILED DESCRIPTION

Examples of the present disclosure include devices and methods tofacilitate, and improve the efficacy and safety of minimally-invasivesurgeries. For example, aspects of the present disclosure may relate tomedical devices and methods for delivering irrigation or suction duringa medical procedure with an additional medical device, such as, forexample, a procedure to remove kidney stones or other material from apatient's kidney or other organ via PCNL with a retrieval basket device.In some embodiments, for example, the medical devices of the presentdisclosure may include or be used with any appropriate insertion sheath,nephroscope, and/or any appropriate medical device to deliver treatment.

Reference will now be made in detail to examples of the presentdisclosure described above and illustrated in the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

The terms “proximal” and “distal” are used herein to refer to therelative positions of the components of an exemplary medical device orinsertion device. When used herein, “proximal” refers to a positionrelatively closer to the exterior of the body or closer to an operatorusing the medical device or insertion device. In contrast, “distal”refers to a position relatively farther away from the operator using themedical device or insertion device, or closer to the interior of thebody.

FIG. 1 illustrates a medical device 10 that includes outer tube 12, adrive wire 14, and a handle 16. Although not shown, medical device 10includes an inner tube (FIGS. 2A and 2B) positioned within outer tube 12and at least partially enclosing drive wire 14. Handle 16 includes adistal arm 18 and a proximal arm 20, with distal arm 18 and proximal arm20 being at least partially pivotable relative to each other via joint22. Outer tube 12 is secured within distal arm 18, and distal arm 18also includes a port 24 such that irrigation or suction may be deliveredvia port 24 through outer tube 12. Drive wire 14 is coupled to proximalarm 20 such that pivoting or compression of proximal arm 20 towards orrelative to distal arm 18 causes drive wire 14 to extend distallythrough the inner tube and outer tube 12.

Outer tube 12 may be a rigid sheath or hollow shaft. An inner tube 34(FIGS. 2A and 2B) at least partially encloses drive wire 14 and ispositioned within outer tube 12. In one aspect, inner tube 34 may besecured to an inner portion of outer tube 12, for example, by anadhesive, laser welding, or other connections.

Drive wire 14 may include an expandable end effector. For example, asshown in FIG. 2A, a self-expandable retrieval basket 32 may be coupledto the distal end of drive wire 14. Therefore, as proximal arm 20 ofhandle 16 pivots relative to distal arm 18, self-expandable retrievalbasket 32 may extend distally of the inner tube and outer tube 12 andexpand, for example, to capture a kidney stone or other material to beremoved. Drive wire 14 may be coupled to proximal arm 20 of handle 16via a drive wire clip 26. In one aspect, drive wire clip 26 may beoperable to disconnect drive wire 14 from handle 16 in order to furtherextend, further retract, or otherwise uncouple drive wire 14, as may benecessary in various medical procedures.

As mentioned, handle 16 includes distal arm 18 and proximal arm 20coupled at joint 22. In one aspect, joint 22 may be a portion of distalarm 18 (as shown), may be a portion of proximal arm 20, or may be aseparate element. Joint 22 may include a torsion spring or other biasingmember (not shown) such that handle 16 may be biased to return to anequilibrium position. For example, a user may hold handle 16 with onehand, and may squeeze handle 16 to compress and move proximal arm 20toward distal arm 18 in order to extend drive wire 14 distally relativeto outer tube 12.

Handle 16 includes port 24. Port 24 is connected to outer tube 12, forexample, through a portion of distal arm 18, for example, through aninternal lumen 40 as shown in FIG. 2A. A suction or irrigation sourcemay be coupled to port 24 to deliver the suction or irrigation throughouter tube 12. Port 24 may include threads, gaskets, etc. to ensure asecure, air-tight connection between handle 16 and a tube connecting thesuction or irrigation source.

Handle 16 may also include a mechanism, such as a button or trigger 28,on distal arm 18 to open or close an internal connection between port 24and outer tube 12. For example, trigger 28 may be spring-biased andoperable to open or close the connection between port 24 and outer tube12. In an extended position, trigger 28 may close the connection betweenport 24 and outer tube 12 such that no suction or irrigation isintroduced into outer tube 12. In a depressed position, trigger 28 mayopen the connection between port 24 and outer tube 12 such that thesuction or irrigation is introduced into outer tube 12.

In an alternative example, trigger 28 may include a variable openingsuch that the degree to which trigger 28 is depressed and/or the amountof pressure applied to trigger 28 is correlated to the size of theopening between port 24 and outer tube 12. The size of the opening maythen correspond to the amount or pressure of the suction or irrigationdelivered through outer tube 12. In an additional aspect, trigger 28 maybe operably replaced by a rotatable dial. In a further aspect, trigger28 may be operably replaced by a foot pedal wirelessly or wiredconnected to handle 16 to control the opening between port 24 and outertube 12.

Furthermore, trigger 28 may include a locking mechanism (not shown) suchthat a user may selectively lock trigger 28 in a depressed configurationsuch that the irrigation or suction may be delivered through outer tube12 without the user maintaining his or her finger on trigger 28. It isalso noted that with trigger 28 depressed, port 24 and outer tube 12 mayprovide a working channel. For example, with trigger 28 depressed andwithout a suction or irrigation source coupled to port 24, a laserfiber, forceps, or other medical element may be inserted through port 24and delivered to the patient lumen through outer tube 12. In anotheraspect, port 24 may include a Y-connector. In this aspect, a suction orirrigation source may be coupled to one port of the Y-connector, and alaser fiber, forceps, or other medical element may be inserted throughthe other port of the Y-connector and delivered to the patient lumen.Alternatively, handle 16 may not include trigger 28, and port 24 andouter tube 12 may provide a working channel for an additional medicaldevice. In any of the above aspects, port 24 may also include a seal orother elements to help prevent a backflow of irrigation or bodilyfluids.

Handle 16 may further include a seal 30 positioned at a proximal end ofdistal arm 18. Seal 30 may surround a portion of drive wire 14. As such,drive wire 14 may move within handle 16 with a reduced risk ofirrigation or bodily fluids escaping from medical device 10 or the usercontaminating the patient's lumen during the procedure.

FIG. 2A illustrates a schematic cross-sectional view of medical device10 with handle 16 in a compressed position and drive wire 14 extendeddistally beyond outer tube 12 to extend an expandable retrieval basket32. The uncompressed position of handle 16 is shown in dashed lines.FIG. 2A illustrates an inner tube 34 positioned within outer tube 12 andenclosing a portion of drive wire 14. Inner tube 34 is shown asextending the length of outer tube 12, but inner tube 34 may also extendproximally of outer tube 12, for example, to seal 30. It is noted thatFIG. 2A does not show drive wire clip 26, but illustrated drive wire 14being coupled to proximal arm 20 via a slot 36.

FIG. 2B illustrates an cross-sectional view of medical device 10. Assuch, FIG. 2B shows inner tube 34 coupled within outer tube 12 viacoupling 38. Drive wire 14 is positioned within inner tube 34. Asmentioned above, in one aspect, coupling 38 may be formed bylaser-welding outer tube 12 and inner tube 34 together.

In one aspect, a user may hold distal arm 18 and proximal arm 20 ofhandle 16 in the user's left or right hand. The user may contract his orher hand, which pivots proximal arm 20 relative to distal arm 18, asshown in FIG. 2A. Pivoting distal arm 20 toward proximal arm 18 extendsdrive wire 14 distally through seal 30 and beyond distal ends of outertube 12 and inner tube 34, expanding retrieval basket 32.

Distal arm 18 of handle 16 also includes an internal lumen 40 connectingport 24 to outer tube 12. Internal lumen 40 may be angled (FIG. 2A).Although not shown, internal lumen 40 may include an adjustable seal orconnection that may be controlled by trigger 28 to open or closeinternal lumen 40. For example, internal lumen 40 may include a pinchingtube that closes internal lumen 40, and actuating trigger 28 may openthe pinching tube and open internal lumen 40. Alternatively, internallumen 40 may be flexible, and actuating trigger 28 may compress thewalls of internal lumen 40 to close internal lumen 40. Moreover,internal lumen 40 provides a conduit for a user to deliver irrigation,suction, or another medical device through port 24 and outer tube 12 totreat a patient.

FIG. 3 illustrates an alternative example according to presentdisclosure, with similar elements to medical device 10 shown by 100added to the reference numbers. Medical device 110 includes outer tube112, inner tube 134, and drive wire 114 coupled to handle 116, andmovement of distal arm 118 and proximal arm 120 relative to each otherextends drive wire 114 distally beyond outer tube 112 and inner tube134. Similarly, handle 116 includes port 124 such that irrigation,suction, or an additional medical device may be delivered throughinternal lumen 140 and outer tube 112 to treat a patient.

In addition to internal lumen 140, medical device 110 includes an innertube lumen 150 within distal arm 118. Inner tube lumen 150 may connectinner tube 134 to an inner tube port 152. In one aspect, inner tubelumen 150 may include two branches, with a first branch connecting toinner tube port 152, and a second branch connecting to seal 130. Asuction or irrigation source (not shown) may be coupled to inner tubeport 152, in the same manner as discussed above with respect to port 24.The suction or irrigation may be activated to surround drive wire 114within inner tube 134. Furthermore, as with port 24, although not shown,handle 116 may further include an additional mechanism operable to open,close, or otherwise adjust a connection between inner tube lumen 150 andinner tube port 152.

For example, during a PCNL procedure, a user may apply energy to breakup one or more kidney stones. The user may insert medical device 110into a patient cavity through an insertion device, for example, aninsertion sheath or a nephroscope. A suction source may be coupled toport 124, and an irrigation source may be coupled to inner tube port152. The user may activate the suction, for example, by depressingtrigger 128, in order to remove small stone fragments, tissue, or otheroccluding material. The user may also deliver irrigation fluid throughinner tube port 152, inner tube lumen 150, and inner tube 134 in orderto, for example, balance the pressure within the patient's cavity duringthe suction and help prevent the patient's cavity from collapsing underthe suction pressure. Delivering irrigation fluid may also aid the userin visualizing the patient's cavity and any material within the cavity.The user may actuate handle 116 by compressing distal arm 118 andproximal handle 120 to extend drive wire 114 distally and to expandretrieval basket 132 to capture a larger stone or piece of material.Drive wire 114 may then be withdrawn proximally into inner tube 134 byallowing joint 122 to bias distal arm 118 and proximal arm 120 towardtheir respective equilibrium positions, enclosing the larger stone orpiece of material within inner tube 134. The stone or piece of materialmay be removed from the patient by withdrawing medical device 110 fromthe insertion sheath or nephroscope.

In another aspect, the user may apply suction through port 124 and outertube 112 to draw a larger stone or piece of material to abut or stick tothe distal end of outer tube 112. While maintaining the suction, theuser may remove medical device 110 from the insertion sheath ornephroscope, with the stone sticking to the distal end of outer tube112. Furthermore, suction through either outer tube 112 or inner tube134 may help draw a stone or material toward medical device 110 to thenbe captured and removed with retrieval basket 132.

Turning now to FIG. 4 , this figure illustrates additional aspects ofthis disclosure that may be incorporated in any of the aforementionedembodiments, with similar elements to medical device 10 shown by 200added to the reference numbers. In particular, FIG. 4 shows a partiallyexploded view of a proximal portion of medical device 210 with drivewire 214 separate from outer tube 212 and handle 216. As in the previousembodiments, distal arm 218 of handle 216 includes port 224 and trigger228.

Proximal arm 220 of handle 216 includes an open top end 260 thatincludes a first slot 262 and a second slot 264 opposite first slot 262.Drive wire clip 226 may be sized to fit within top end 260 between firstslot 262 and second slot 264. Drive wire clip 226 may include a thumbpad 266 and a protrusion 268 extending proximally such that, whencoupled to handle 216, drive wire clip 226 may slide within open top end260 with protrusion 268 through second slot 264. The movement of drivewire clip 226 relative to proximal arm 220 may be biased by a spring270.

Drive wire clip 226 also includes a wire slot 272 substantially alignedwith and narrower than first slot 262. Wire slot 272 extends verticallythrough a distal portion of drive wire clip 226 and includes a releaseportion 274. Drive wire 214 includes a coupling portion 276 at aproximal portion of drive wire 214. Medical device 210 further includesa cap 278, which may be snap coupled or otherwise secured over open topend 260 of proximal arm 220 to enclose drive wire clip 226 and spring270 within open top end 260.

As shown in FIG. 4 , drive wire 214 may be coupled to drive wire clip226 with coupling portion 276 fitting within wire slot 272. Drive wire214 may be coupled to drive wire clip 226 by inserting coupling portion276 through release portion 274. In an equilibrium position, spring 270and cap 278 may position drive wire clip 226 within open top end 260such that drive wire 214 is within wire slot 272 below release portion274. Coupling portion 276 helps to ensure that drive wire 214 remainscoupled to drive wire clip 226 within proximal arm 220. The user may acton handle 216 as discussed above to deliver suction or irrigation and toextend a distal end of drive wire 214 distally beyond outer tube 212 andinner tube (not shown). In an instance where it is necessary or desiredto disconnect a proximal end of drive wire 214 from handle 216, the usermay depress drive wire clip 226 by sliding thumb pad 266 and protrusion268 downward within second slot 264, compressing spring 270. Drive wire214 is at least partially rigid, so as drive wire clip 226 slidesdownward, drive wire 214 and coupling portion 276 remain stationarywithin drive wire clip 224. If drive wire clip 226 is fully depressed,coupling portion 276 may align with release portion 274. Then, forcesacting on drive wire 214 from a distally positioned stone or imparted onthe proximal end of drive wire 214 by the user may slide couplingportion 276 out of release portion 274, disconnecting the proximal endof drive wire 214 from drive wire clip 224 and proximal arm 220.Slidable drive wire clip 226 may help a user to disconnect drive wire214 without the assistance of another medical professional and withoutthe need to remove an additional element or piece from medical device210.

While release portion 274 and coupling portion 276 are shown as circularin FIG. 4 , this disclosure is not so limited. In one aspect, bothelements may be triangular, rectangular, pentagonal, etc., or otherwisemirror each other such that drive wire 214 may be coupled within wireslot 272 and be released from drive wire clip 226 through releaseportion 274 when drive wire clip 226 is depressed.

FIGS. 5A and 5B illustrate additional features according to aspects ofthis disclosure. Specifically, FIGS. 5A and 5B illustrate additionalfeatures that may aid a user in coupling and uncoupling a drive wire anda handle, with similar elements to medical device 10 shown by 300 addedto the reference numbers. FIGS. 5A and 5B show perspective views of aportion of medical device 310 with drive wire 314 coupled to handle 316.In particular, proximal arm 320 includes a wire slit 380 in a topportion of proximal arm 320. A screw tab 382 may be coupled to proximalarm 320, and with screw tab 382 coupled to proximal arm 320, drive wire314 may be pinched or otherwise secured within wire slit 380 (FIG. 5A).In particular, wire slit 380 may be biased outwardly to form a widerslit, and screw tab 382 may be attached to a threading 388 (FIG. 5B) topinch or compress wire slit 380 to secure drive wire 314 to proximal arm320. Screw tab 382 may include an internal threading (not shown) and aprojection 384, which may help a user actuate, grip, or rotate screw tab382. Screw tab 382 may be couplable to a threading 388 on proximal arm320 (FIG. 5B). In one aspect, a user may hold handle 316 in one hand,and may use his or her other hand to rotate screw tab 382. In anotheraspect, the user may hold handle 316 in one hand, and may use the thumbof the same hand to rotate screw tab 382.

With drive wire 314 secured within wire slit, a user may deliver andactuate medical device 310 as discussed above in order to extend thedistal end of drive wire 314. Although medical device 310 includes abend joint 386 connecting distal arm 318 and proximal arm 320, bendjoint 386 may bias handle 316 to a retracted position as discussed abovewith respect to joint 22.

If it is necessary or desired to disconnect drive wire 314 from handle316, the user may rotate screw tab 382, for example, in direction A.Rotating screw tab 382 may disconnect screw tab 382 from a threading 388on proximal arm 320. As shown in FIG. 5B, wire slit 380 may extendthrough a middle portion of threading 388. With screw tab 382disconnected, wire slit 380 may expand or widen, allowing drive wire 314to move within and disconnect from wire slit 380. Therefore, the usermay disconnect drive wire 314 from proximal arm 320 without theassistance of another medical professional. Furthermore, if it isdesired, the user may recouple drive wire 314 in slit 380 by positioningdrive wire 314 in slit 380 and screwing screw tab 382 over threading 388to pinch or compress slit 380 and couple drive wire 314 to proximal arm320.

FIGS. 6A and 6B illustrate additional features according to aspects ofthe present disclosure. Specifically, FIGS. 6A and 6B illustrateadditional features that may aid a user in capturing or releasingmaterial, for example, a kidney stone, with similar elements to medicaldevice 10 shown by 400 added to the reference numbers. FIGS. 6A and 6Bshow side and perspective views of a portion of medical device 410 withouter tube 412 and drive wire 414 coupled to handle 416.

In particular, handle 416 includes a lever 490 slidably positionedwithin a slot 492. Lever 490 and slot 492 may be positioned on a distalextension 494 extending from distal arm 418 of handle 416. Slot 492 maybe located in a bottom portion of distal extension 494. In one aspect,lever 490 is fixedly coupled to outer tube 412, such that movement oflever 490 within slot 492 translates outer tube 412. For example, ifretrieval basket 432 is extended, a user may move lever 490 proximallyin direction B, causing outer tube 412 to retract proximally and, thus,causing retrieval basket 432 to further expand in size and/or changeshape. In one aspect, retrieval basket 432 may include a shape memoryalloy that expands or changes shape as retrieval basket 432 isuncovered. The proximal movement of lever 490 may be biased by aninternal spring (not shown) within distal arm 418 or distal extension494. It is noted that drive wire 414 passes through outer tube 412 andlever 492 to connected to proximal arm 420 as discussed above, forexample, via drive wire clip 426.

Moreover, it is noted that the position and orientation of lever 490,for example, proximate to and parallel to distal arm 418, may help toallow a user to comfortably hold and manipulate the elements of medicaldevice 410. In one aspect, the user may hold distal arm 418 and proximalarm 420 of medical device 410 in one hand, and the user can use one ormore fingers of the same hand or the user's other hand to manipulatelever 490. It is noted that lever 490 and slot 492 may be positioned ondistal extension 494 in different locations or positions, for example,on top or side portions of distal extension 494. Medical device 410 mayalso include a locking device (not shown) in order for a user toselective lock lever 490 in various positions within slot 492.Additionally, slot 492 may include one or more indications or indiciaadjacent to a length of slot 492 to indicate to the user variouspositions that correspond to various sizes or shapes of retrieval basket432.

As such, a user may deliver and actuate medical device 410 as discussedabove in order to extend the distal end of drive wire 414 by relativemovement of distal arm 418 and proximal arm 420. Extending the distalend of drive wire 414 extends retrieval basket 432, for example, aself-expanding basket, in order to capture material within retrievalbasket 432. In some instances, the material may be too large or oddlyshaped to be withdrawn through outer tube 412, an internal sheath, oranother insertion device used during the procedure to deliver medicaldevice 410. In such an instance, the user may seek to release thematerial from retrieval basket 432. As such, the user may proximallyretract lever 490, retracting outer tube 412 and expanding retrievalbasket 432, which may help to release the material from retrieval basket432.

As shown in FIG. 6A, retrieval basket 432 may include a first size andshape, which corresponds to handle 416 being fully contracted. Retrievalbasket 432 may transition to retrieval basket 432′. Retrieval basket432′ includes a second size and shape, and corresponds to handle 416(i.e., distal arm 418 and proximal arm 420) being fully contracted andlever 490 being fully proximally retracted. For example, retrievalbasket 432 may include a diameter C of approximately 16 mm, andretrieval basket 432′ may include a diameter D of approximately 20 mm.In another aspect, retracting lever 490 and outer tube 412 proximallymay both expand and change the shape of retrieval basket 432. Forexample, although not shown, a first shape may be substantiallyelliptical (e.g., a 16 mm elliptical basket), and second shape may besubstantially spherical or rounded (e.g., a 20 mm spherical basket). Asmaller size or elliptical shape may include smaller spaces or gapsbetween struts of retrieval basket 432, and a larger size or sphericalshape may include larger spaces or gaps between struts of retrievalbasket 432′. As such, one size or shape may be helpful in retaining asmaller stone or piece of material, while another size or shape may behelpful in releasing a larger stone or piece of material.

In another aspect, the user may utilize the lever to extend and expandretrieval basket 432 such that retrieval basket 432 is positioneddistally beyond the material to be captured. The user may then capturethe material by releasing lever 490 such that the material is capturedas retrieval basket 432 reduces in size and retracts proximally, movingtoward outer tube 412 or another insertion device.

FIGS. 7A and 7B illustrate additional features according to aspects ofthe present disclosure. Specifically, FIGS. 7A and 7B illustrateadditional features that may aid a user in manipulating a retrievalbasket while capturing or releasing material, for example, a kidneystone, with similar elements to medical device 10 shown by 500 added tothe reference numbers. FIGS. 7A and 7B show side and cross-sectionalviews of a portion of medical device 510 with outer tube 512 and drivewire 514 coupled to handle 516.

FIG. 7A illustrates a portion of medical device 510 with handle (notshown) compressed to extend retrieval basket 532 distally from outertube 512. Similar to medical device 410, medical device 510 includes adistal extension 594 extending from distal arm 518. Outer tube 512 isfixed to or otherwise positioned within distal extension 594. Medicaldevice 510 further includes a rotary knob 596. Rotary knob 596 may bepositioned within a U-shaped opening between a proximal portion 594A anda distal portion 594B of distal extension 594. Proximal portion 594A anddistal portion 594B are connected by a connecting or bridge element 598that encloses a portion of rotary knob 596 by extending between, forexample, bottom portions of proximal portion 594A and distal portion594B. Although not shown, medical device 510 may include an additionalbridge element 598 connecting top portions of proximal portion 594A anddistal portion 594B to surround rotary knob 596 on both a bottom sideand a top side.

As shown in FIG. 7B, rotary knob 596 radially surrounds a portion ofdrive wire 514. Additionally, drive wire 514 may include a shaft 501radially surrounding a portion of drive wire 514, between drive wire 514and rotary knob 596. Shaft 501 may be secured to a portion of drive wire514 via adhesive, welding, crimping, or otherwise fixedly coupled. Shaft501 and rotary knob 596 may include at least one engaging surface suchthat rotation of rotary knob 596 rotates shaft 501, and thus alsorotates drive wire 514 and retrieval basket 532. For example, an outersurface of shaft 501 and an inner surface of rotary knob 596 may besquare or rectangular (FIG. 7B), may be pentagonal, hexagonal, etc. Inanother aspect, the outer surface of shaft 501 may include a protrusion,and the inner surface of rotary knob 596 may include an indentation toreceive the protrusion, or vice versa. In any of the aforementionedaspects, the engagement between rotary knob 596 and shaft 501 allows forshaft 501 to slide longitudinally through, proximally or distally,rotary knob 596. Furthermore, as shown in FIG. 7B, shaft 501 extendslongitudinally around drive wire 514 longer than the length of rotaryknob 596. For example, with handle 516 of medical device 510 notcompressed and with distal arm 518 and proximal arm (not shown) in anequilibrium position, shaft 501 may extend from a distal edge of rotaryknob 596 to just distal to the coupling of drive wire 514 to theproximal arm. Alternatively, shaft 501 may also be coupled to theproximal arm. As drive wire 514 and shaft 501 pass through rotary knob596 due to action on handle 516 of medical device 510, rotary knob 596and shaft 501 maintain at least one engaging surface. Therefore, theuser may rotate rotary knob 596 to rotate shaft 501 and drive wire 514,and thus rotate retrieval basket 532, throughout the extension andretraction of drive wire 514. Although not shown, medical device 510 mayfurther include a locking mechanism to secure a position of rotary knob596 relative to distal extension 594.

A user may deliver and actuate medical device 510 as discussed above inorder to extend the distal end of drive wire 514 by relative movement ofdistal arm 518 and proximal arm (not shown). Extending the distal end ofdrive wire 514 extends retrieval basket 532, for example, aself-expanding basket, in order to capture material within retrievalbasket 532. Additionally, extending the drive wire 514 slides shaft 501distally through rotary knob 596. During any stage of the extension andexpansion, the user may act on rotary knob 596 to rotate drive wire 514and retrieval basket 532 due to the interlocking arrangement of shaft501 and rotary knob 596. For example, rotating rotary knob 596 indirection E also rotates retrieval basket in direction E (FIG. 7A). Theuser may act on rotary knob 596 with a finger or fingers of one handwhile holding handle 516 in the same hand. Alternatively, the user mayact on rotary knob 596 with a finger or finger of the user's other handto rotate retrieval basket 596. Rotation of retrieval basket 596 mayhelp a user capture or release a kidney stone or other piece of materialby allowing the user to selectively position the struts of retrievalbasket 596 relative to the material without rotating his or her hand orwrist. Therefore, drive wire 514 and retrieval basket 532 include twodegrees of movement—longitudinal translation via relative compression ofdistal arm 518 and the proximal arm, and rotation via action on rotaryknob 596.

The disclosed medical devices 10, 110, 210, 310, 410, and 510 andportions thereof shown in the figures and discussed above may allow auser to control the suction, irrigation, and extension of medicaldevices to a patient's lumen. The devices 10, 110, 210, 310, 410, and510 and portions thereof may also help enable efficient and effectiveprocedures to remove material from a patient, while also providingirrigation to maintain a safe pressure within the cavity and helpprevent the patient's lumen from collapsing. The irrigation may alsoenhance visualization during the medical procedure. For example, a usermay insert a nephroscope to a patient's kidney and apply energy to breakup one or more kidney stones. The user may remove the energy source andthen insert one of medical devices 10, 110, 210, 310, 410, or 510through the nephroscope. The user may remove smaller stone particles bydelivering suction through port 24 and outer tube 12. Withoutrepositioning medical device 10, 110, 210, 310, 410, or 510, the usermay compress the handle to extend a retrieval basket 32 or other medicaldevice to capture a larger piece of stone material, with the bias of thehandle withdrawing the material within inner tube 34. The user may thenremove the medical device from the nephroscope, with the stone materialenclosed within inner tube 34.

In an additional aspect, the captured stone material may be too large tobe enclosed within inner tube 34. In this aspect, medical devices 210and 310 illustrate aspects that may be used to disconnect the drive wire214, 314 and/or dismantle the medical devices. Such aspects may be usedto disconnect the drive wire and manually push or pull the drive wire.Additionally, such aspects may be used to disconnect the drive wire andremove the remainder of the medical device from the nephroscope in orderfor a lithotripter or other energy source to be reinserted and deliveradditional energy to the stone material captured within the retrievalbasket. Moreover, these aspects may be performed by a user without theassistance of another medical professional and without the need toremove an additional element or piece from the medical device.

Medical devices 410 and 510 illustrate aspects that may be used tocapture and release the stone material. For example, medical device 410may aid in the capture or release of the stone material by allowing theuser to manipulate the size and shape of retrieval basket 432 throughaction on lever 490 to retract outer tube 412. Furthermore, medicaldevice 510 may also help a user in the capture or release of the stonematerial by allowing the user to manipulate the position of drive wire514, and thus retrieval basket 534, by rotating rotary knob 596.Rotating retrieval basket 534 may help the user to position individualstruts of retrieval basket 534 relative to the stone material. A usermay be able to rotate retrieval basket 596 by rotating rotary knob 596,and thus not have to rotate his or her hand or wrist while holdingmedical device 510. It is also noted that, although not shown, medicaldevices 410 and 510 may include inner tubes, ports, and other featuresdiscussed with respect to medical devices 10, 110, 210, and 310 in orderto deliver irrigation and suction through outer tube 412, 512 or tocouple and uncouple drive wire 414, 514 to the proximal arm of handle416, 516.

While much of this disclosure is directed to percutaneousnephrolithotomy (PCNL) with or without lithotripsy, it is furthercontemplated that the systems and procedures discussed herein may beequally applicable to other material removal procedures. For example,the devices and methods discussed above may be used during aureteroscopic kidney stone removal. The devices and methods discussedabove may also be used in procedures to remove ureteral stones,gallstones, bile duct stones, polyps, etc.

While principles of the present disclosure are described herein withreference to illustrative examples for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications,embodiments, and substitution of equivalents all fall within the scopeof the features described herein. Accordingly, the claimed features arenot to be considered as limited by the foregoing description.

We claim:
 1. A medical device comprising: a handle including a proximalarm and a distal arm, wherein the proximal arm and the distal arm arepivotable via a joint, and wherein the distal arm includes a handleport; an outer tube coupled to the distal arm and fluidly coupled to thehandle port; an inner tube positioned within the outer tube; and a drivewire, wherein a portion of the drive wire is positioned within the innertube, and wherein a different portion of the drive wire extendsproximally of the distal arm and is coupled to the proximal arm, whereinthe drive wire is releasably coupled to the proximal arm of the handlevia a depressible and slotted drive wire clip, and wherein the drivewire clip is biased toward an extended position by a spring within theproximal arm.
 2. The medical device of claim 1, further including amechanism to open or close a connection between the handle port and theouter tube.
 3. The medical device of claim 2, wherein the mechanism is atrigger.
 4. The medical device of claim 2, wherein the mechanism is adial, and wherein the connection between the handle port and the outertube includes a variable opening.
 5. The medical device of claim 1,further including an inner tube port in the distal arm that is fluidlyconnected to the inner tube.
 6. The medical device of claim 5, whereinthe handle port is configured to be connected to a suction source todeliver suction through the outer tube, and wherein the inner tube portis configured to be connected to an irrigation source to deliverirrigation through the inner tube and around the drive wire.
 7. Themedical device of claim 6, further including a mechanism to open orclose a connection between the inner tube port and the inner tube. 8.The medical device of claim 1, wherein the medical device is configuredto be held in a user's hand, and wherein the drive wire clip isconfigured to be actuated by a thumb of the user's hand.
 9. The medicaldevice of claim 1, wherein the inner tube is secured within the outertube through laser welding; and wherein the joint includes a torsionspring.
 10. The medical device of claim 9, wherein a distal end of thedrive wire includes an expandable retrieval basket; and wherein aproximal portion of the distal arm includes a seal; and wherein thedrive wire is movable through the seal.
 11. A medical device handlecomprising: a distal arm, including a first internal lumen fluidlyconnected to a first port, and a second internal lumen fluidly connectedto a second port; a proximal arm; an outer tube coupled to the firstinternal lumen; an inner tube within the outer tube and coupled to thesecond internal lumen; a drive wire clip, wherein the drive wire clipincludes a slot and is depressible within a portion of the proximal arm;and a drive wire including an expandable end effector at a distal end ofthe drive wire, wherein a portion of the drive wire is positioned withinthe inner tube and moveable through the second internal lumen, wherein aproximal portion of the drive wire extends proximally of the distal armand is releasably coupled to a distal portion of the proximal arm,wherein the drive wire is releasably coupled to the distal portion ofthe proximal arm via the drive wire clip, and wherein the drive wireclip is biased toward an extended position by a spring within theproximal arm; wherein the proximal arm and the distal arm are pivotablevia a joint, and wherein pivoting of the proximal arm and the distal armextends or retracts the drive wire from a distal end of the inner tube;and wherein the drive wire clip is operable to disconnect the drive wirefrom the proximal arm.
 12. The medical device handle of claim 11,further including a mechanism to adjustably control a flow of suction orirrigation through the first internal lumen.
 13. The medical devicehandle of claim 11, further including a first tube coupled to the firstinternal lumen and a second tube coupled to the second internal lumen,wherein the second tube is positioned within the first tube; and whereinthe first port is configured to be connected to a suction source todeliver suction through first internal lumen and the outer tube tosurround the inner tube.
 14. The medical device handle of claim 11,wherein the drive wire clip is movable within an opening in the proximalarm, wherein the slot of the drive wire clip includes a release portion,wherein the proximal portion of the drive wire includes a couplingportion configured to be retained within the slot and slide through therelease portion, and wherein movement of the drive wire clip within theopening in the proximal arm positions the coupling portion within therelease portion.